NAC639.67063. Low-risk sterile compounding: Radiopharmaceutical drug products.

If a nuclear pharmacy compounds radiopharmaceutical drug products, the nuclear pharmacy shall ensure that, in addition to satisfying the requirements of NAC 639.5828:

     1. The radiopharmaceutical compounded drug products are compounded in a vertical laminar airflow hood or Class II type B2 biological safety cabinet that is located in an environment with an air quality of ISO Class 8 or higher;

     2. Only shielded vials, syringes and other devices and containers specifically manufactured for use with radiopharmaceutical components are used in the compounding process;

     3. Each employee of the nuclear pharmacy who will compound radiopharmaceutical drug products is trained and knowledgeable with regard to compounding, handling, cleaning and any special techniques used with radiopharmaceutical drug products; and

     4. Any special equipment or device that is used to compound radiopharmaceutical products, including, without limitation, a molybdenum-99technetiym-99m generator, is used, stored and maintained according to the directions of the manufacturer of the equipment or device.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)